Kornimate/medical-research-clean huggingface dataset:
clinical study of autologous tumor-infiltrating lymphocyte injection (gt201) for advanced solid tumors

Conditions: Solid Tumor

Summary: this study is a multi-center, single-arm phase i clinical trial. a total of 26\~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. an "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (fc regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.the study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period


Eligibility criteria:
inclusion criteria: * 1.voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. 2.at least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. 3.eastern collaborative oncology group (ecog) physical fitness status score of 0 or 1. exclusion criteria: * 1.failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment. 2.people with uncontrolled tumor-related pain as judged by the investigator. 3.risk of major bleeding as assessed by investigators. 4.have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function. 5.any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy . 6.history of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (dmso), human serum albumin (hsa), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.women who are pregnant or breastfeeding;
periodontal outcomes and digital volumetric variation following bopt restorations

Conditions: Gingival Recession

Summary: technology is becoming increasingly essential in dentistry, and many procedures now require the use of an intraoral scanner. the goal of scanning the oral cavity is to create digital impressions, which are crucial for the fabrication of any dental prosthesis, as three-dimensional models of the dentition are needed. alongside technological advancements, new techniques for preparation in fixed dental prosthetics are being developed. an example is the bopt technique, which involves vertical tooth preparation without a finishing line, associated with gingival sulcus curettage. the technique aims to improve the health and stability of gingival tissues over time. since it is a technique still not widely used, there is a need to intensify studies on the subject, justifying the conduct of this observational research aimed at assessing, through scanning and image overlay programs, the volumetric change of gingival tissues after the installation of ceramic prostheses with bopt-type carving

the aim of this study was to analyze the behavior of the periodontal tissues around teeth in the anterior region when restored with zirconia single crowns, using a biologically oriented preparation technique (bopt). the study will investigate tooth-supported single crowns in the anterior region that were fabricated with a full zirconia core, in 18 patients, in the past 3 years. follow-up analysis will measure periodontal responses by evaluating the following variables: plaque index (pi); probing depth (pd); gingival index (gi); and gingival thickness adjacent to the restoration using intraoral scanning. the images of the scanning before and after bopt restoration will be overlap by using a software tool named geomagic. this program can quantify the changes of gingival thickness in different points defined by the investigator.

Eligibility criteria:
inclusion criteria: * patients who had been treated previously by bopt technique. * patients aged over 18 years. exclusion criteria: * cases where the scanners cannot be overlapping.
involvement of transverso-sacral- neo- articulations or of transverso-iliac articulations in chronic lumbago

Conditions: Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

Summary: the specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.the primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit s4 (visit 4 weeks after the infiltration)


Eligibility criteria:
inclusion criteria: * adult with age equal or above to 18. * subject affiliated to french health insurance (sécurité sociale) * lateralized lumbago on side of the neo-articulation evolving since more than 3 months * mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee) * mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- pain induced by palpation in regards to the neo-articulation * pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics * no clinical proof for a discal origin : inducing factor, impulsiveness, spinal syndrome, true lasègue * transverse-sacral abnormality of iib, iiia, iiic or iv type with neo-articulation lateralized on side of pain * informed consent form signed exclusion criteria: * age below 18 * clinical arguments in favour of a discal origin * pregnant women or women that could become pregnant the day of the infiltration * diabetic patient * patient unable to understand the protocol * no autonomy for coming to the hospital (no budget allocated for patient transportation) * hypersensitivity to local anesthetics with "liaison amide" * hypersensitivity to one of the components * porphyria- local or generalized infection, suspiscion of infection * severe troubles of coagulation, anti-coagulant treatment taken * bilateral lumbago with bilateral neo-articulation
cohort study of heart rate variability

Conditions: Cardiovascular Diseases; Myocardial Ischemia; Carotid Stenosis; Hypertension; Diabetes Mellitus; Heart Diseases

Summary: to examine factors affecting heart rate variability (hrv) and the role of hrv in heart disease. specifically, to examine the role of hrv: as a predictor of fatal and nonfatal ischemic heart disease over a six year follow-up of the atherosclerosis risk in communities (aric) population based, bi-ethnic cohort; on the six year progression of carotid atherosclerosis measured by b-mode ultrasound; and on the incidence of hypertension. also, to study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic abnormalities on changes in hrv over nine years of follow-up.

background: heart rate variability analysis has been widely used in clinical research as a noninvasive measurement of autonomic function. it has been found to be associated with post-myocardial infarction mortality, hypertension, sudden cardiac death, atherosclerosis, and diabetes. however, little epidemiologic research on hrv had been reported prior to this study in 1996. almost no data were available on the population distribution of hrv, its correlates in populations, the factors associated with changes in hrv over time, or on the cardiovascular sequelae of impaired autonomic function assessed by hrv obtained from population-based prospective studies. design narrative: the study was ancillary to aric, a population-based, longitudinal study of cardiovascular and pulmonary diseases. the baseline exam was completed in 1987 to 1988, followed by yearly contacts and re-examinations every three years. the present study built on the data collected by the aric investigators by retrieving and processing beat-to-beat heart rate data collected during the baseline exam. five minutes of beat-to-beat heart rate data were obtained from the aric cohort participants during their third follow-up visit (visit) 4 in 1996 through 1998. time and frequency domain hrv indices were derived for an assessment of autonomic function. the following hrv indices were computed both for the baseline and the nine-year follow-up exam (1996 through 1998) on the 13,000 members of the aric cohort: time domain indices; mean heart rate, minimum and maximum heart rate, standard deviation of all normal r-r intervals, the coefficient of variation of all normal r-r intervals, root mean square of the differences of successive r-r intervals, and the proportion of adjacent r-r intervals. frequency domain indices were also computed, including high frequency power, low frequency power, and the high/low frequency power ratio.

Eligibility criteria:
residents of 4 geographically defined areas
the effect vitamin d on the recovery rate of bell palsy

Conditions: Bell Palsy; Vitamin D Deficiency; Facial Paralysis

Summary: patients aged between 18-65 who visit the physical medicine and rehabilitation outpatient clinic diagnosed with bell palsy will be included in the study. the patients' bell palsy grade will be evaluated by houseman brahman (hb) scale and their disability level will be evaluated by facial disability index (fdi). their serum vitamin d level will be noted. the patients having vitamin d deficiency will be randomized into two groups. group 1 will be given 50.000 iu/week vitamin d replacement for 8 weeks. all the patients will be included in a standard physical therapy and home exercise program. both groups will be asked for a control visit at weeks 8.their clinical recovery will be evaluated by hb staging and fdi by the physical medicine and rehabilitation specialist who is blind to the randomization.

patients aged between 18-65 who visit the physical medicine and rehabilitation outpatient clinic diagnosed with bell palsy will be included in the study. facial palsy stages of patients will be graded from 1 to 6 according to the houseman brahman (hb) staging system. in order to determine the disability criteria of the patients, a form called facial disability index (fdi)-facial disability index will be filled. this scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. the patients having vitamin d deficiency will be randomized into two groups. one group will be getting a vitamin d replacement treatment for 8 weeks. a physical therapy program in the form of a standard exercise program including electrical stimulation and facial paralysis exercises will be organized for all the patients. the patients will be evaluated at 8th week by hb and fdi.

Eligibility criteria:
inclusion criteria: * being cooperative-orientated * willing to participate in the physical therapy home exercise program exclusion criteria: * being non cooperative, disorientated * failure to comply with the physical therapy home exercise program * history of malignancy * additional neurological disease * having cranial pathologies
acoustic analytic apps for smart telehealth screening - creating a big data

Conditions: URTI; Cough; Cough Variant Asthma; Cough; Bronchial, With Grippe or Influenza

Summary: to develop and validate a library of cough spectrum from a target of 1000 cough acoustics. coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. cough acoustic in absence of respiratory disease is also included. this is a prospective observation cohort study recruiting children below the age of 16 years old in 2 arms : (1) patients with respiratory conditions presenting with cough and (2) well patients without active coughing.

cough is a common presentation in childhood. it is one of the early symptom of respiratory disease such as upper respiratory tract infection, cough variant asthma, allergic rhinitis, bronchitis and pneumonia. these conditions are common ailments in childhood. the history of cough and description of cough given by caretakers and patients are often vague and assessment of cough quality is often subjective. the quality of cough is often assigned a dichotomous category of dry cough and wet cough. computer assisted cough analysis has been developed in recent years to aid subjective classification of cough. the sound spectrum and frequencies of cough is being researched to better define the quality of cough. the quality of cough gives meaningful information about the state of the respiratory status. cough sound analysis has been shown to rapidly diagnose pneumonia in humans using cough sound analysis and in differentiating wet and dry cough. the investigators hypothesize that each respiratory pathology will have its spectral cough characteristics. analysis of cough spectrum and comparing to a library of cough spectra data will be able to aid differentiation of the underlying conditions for the various cough spectrum and hence facilitating management. the study aim is to develop a computer processing technique of cough sounds and determine their spectral characteristics for the common causes of cough to derive an assisted assay of cough spectrum for an objective assessment of cough.

Eligibility criteria:
inclusion criteria: * cough arm 1.children age 16 years old and below with cough at presentation- patients presenting with active or chronic or residual cough well arm 1.children age 16 years old and below and well with no cough presentation. exclusion criteria: 1. children with severe behavioral 2. droplet isloated cases as determined by protocol of hospital
phase iii study of two different schedules (weekly and tri-weekly) of combination of gemcitabine and two taxanes in mbc

Conditions: Metastatic Breast Cancer (MBC)

Summary: multi-center, randomized phase iii study. 4 arms. 360 patient to enroll. purpose is evaluate time to progression disease (pd).


Eligibility criteria:
inclusion criteria: * histologic diagnosis of metastatic breast cancer (mbc). * prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen. * relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated. * patients with measurable disease. * previous hormonal therapy for adjuvant setting or metastatic disease. exclusion criteria: * previous chemotherapy for mbc * previous chemotherapy with gemcitabine in any setting of disease * patient candidable to treatment with trastuzumab.
premotor cortex: a new target for stroke motor rehabilitation

Conditions: Stroke

Summary: the goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rtms) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

motor training is an important part of recovery after stroke. during motor training, stroke patients practice performing a movement and become better at performing the trained movement over time. repetitive transcranial magnetic stimulation (rtms), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. healthy adults made larger training-related improvements in their motor performance when they received rtms over the primary motor cortex during motor training. there is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rtms for some stroke survivors. in the current study, the investigator will determine the effect of rtms over the premotor cortex on training-related improvements in motor performance in healthy adults.

Eligibility criteria:
inclusion criteria: motor training only (pilot participants): * have the ability to give informed, written consent * be aged 18-80 years old * be right-handed using the edinburgh handedness inventory * have intact cognitive abilities (score higher than 75th percentile on the repeatable battery for the assessment of neuropsychological status (rbans)) * no current depression (score less than 7 on the hamilton depression rating scale (hdrs)) * no neurological disease * no contradictions to transcranial magnetic stimulation (tms) * tms over the extensor carpi ulnaris (ecu) hotspot must evoke a motor evoked potential (mep) in the ecu muscle * mep amplitude must increase by at least 20% as the tms intensity increases * the subjects must be comfortable when receiving tms of all strengths. remaining study participants: * have the ability to give informed, written consent * be aged 55-80 years old * be right-handed using the edinburgh handedness inventory * have intact cognitive abilities (score higher than 75th percentile on the repeatable battery for the assessment of neuropsychological status (rbans)) * no current depression (score less than a 7 on the hamilton depression rating scale (hdrs)) * no neurological disease * no contradictions to transcranial magnetic stimulation (tms) * tms over the extensor carpi ulnaris (ecu) hotspot must be able to evoke a motor evoked potential (mep) in the ecu muscle * mep amplitude must increase by at least 20% as the tms intensity increases * the subjects must be comfortable when receiving tms of all strengths. exclusion criteria: * impaired cognitive abilities (score lesser than 75th percentile on the repeatable battery for the assessment of neuropsychological status (rbans)) * current depression (score more than 7 on the hamilton depression rating scale (hdrs)) * neurological disease * has a contradiction to tms * mep cannot be evoked with tms in the ecu muscle * inability to tolerate one or more tms strengths

Keywords: transcranial magnetic stimulation
glycemic profiles and insulin delivery across the menstrual cycle in women with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: this is an observational study. forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. study participants will include free-cycling females and females following oral contraceptive therapy. all study appointments may be completed virtually.

females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (cgm) in order to collect 3 full menstrual cycle data within 180 days. enrollment may last from 3-5 months. study participants will include free-cycling females and females following oral contraceptive therapy. study cgms and activity trackers will be provided for the entire data collection period. during data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. the clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).

Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * use of glucose sensor in the last 6 months * use of insulin pump in the last 6 months * age ≥18 to ≤40 years * hba1c ≤8.5% if measured at screening or available from historical medical report performed within the last 6 months; in absence of a valid hba1c measurement, average blood glucose estimated from cgm data to be approximately 200 mg/dl or less * absence of perimenopausal/menopausal symptoms * willingness to keep track of beginning of menstrual cycle * willingness to keep track of ingested carbohydrates * willingness to not become pregnant during study participation * regularly menstruating (at least every month with no missed cycles) * only free-cycling participants: willingness to use ovulation kits to confirm ovulation * only participants under oral contraceptive therapy: use of monophasic pill, with 3 weeks of active pill and 1 week of placebo * willingness to use the study dexcom g6 during the study * participants must have internet access and a computer system that meets the requirements for uploading the study equipment exclusion criteria: * pregnancy * hormonal birth control therapy except monophasic pill contraceptive * polycystic ovary syndrome (pcos) diagnosis * current use of steroids * concurrent use of any non-insulin glucose-lowering agent (including glp-1 agonists, pramlintide, dpp-4 inhibitors, sglt-2 inhibitors, sulfonylureas, metformin) * uncontrolled thyroid disease * active fertility treatment * concomitant disease or condition that may compromise patient safety or ability to follow the protocol including: planned or current dialysis treatment; moderate to advanced nephropathy; known or suspected allergy to medical grade adhesives. * severe hypoglycemia or diabetes ketoacidosis (dka) in the previous 6 months

Keywords: menstrual cycle continuous glucose monitor (cgm) oral contraceptives free cycling